Status:
UNKNOWN
Recurrent Urinary Tract Infections and Heparin (RUTIH Trial)
Lead Sponsor:
University of Oklahoma
Conditions:
Recurrent Urinary Tract Infections
Eligibility:
FEMALE
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
Urinary Tract Infections (UTIs) are the second most common infection in the body. UTIs account for five percent of all visits to primary care physicians. Many women who have had a UTI will develop rec...
Detailed Description
Primary Objectives: The specific aims of this study are to 1) demonstrate that Heparin bladder instillations reduce the number of UTI episodes; 2) demonstrate Heparin bladder instillations increase me...
Eligibility Criteria
Inclusion
- Women aged 18-85 with history of recurrent urinary tract infections.
- Definition of Recurrent UTI: if experienced either more than 3 symptomatic UTI episodes in the past year (including the index infection) or 2 such episodes in the past 6 months.
- Definition of UTI: \>103 cfu/mL of a uropathogen in midstream urine culture from a woman experiencing more than 2 symptoms of cystitis (dysuria, urgency, frequency, suprapubic pain, or hematuria) or, in the absence of a culture, demonstration of pyuria on urinalysis and more than 2 urinary symptoms, as well as complete and rapid resolution of symptoms in response to antibiotic therapy for UTI.
Exclusion
- Taking any anticoagulant such as warfarin sodium, heparin
- Taking any thrombolytic agent such as a tissue plasminogen activator or streptokinase
- Known aneurysm, thrombocytopenia, hemorrhagic disease, hemophilia, gastrointestinal ulceration, polyps, or diverticula
- Known hypersensitivity to heparin
- History of, or currently has neurogenic bladder, pelvic irradiation or chemical cystitis
- Presence of urethral, pelvic, or rectal carcinoma, Benign or malignant bladder tumors
- Tuberculous cystitis, urinary schistosomiasis
- Bladder or ureteral calculi, urethral or bladder obstruction, augmentation cystoplasty, cystectomy, supratrigonal denervation of the bladder (cystolysis), neurectomy, or implanted peripheral nerve stimulator that has affected bladder function; Microscopic hematuria as defined as \> 5 red blood cells (RBC) /high power field at baseline visit without a negative workup within the last year
- Positive pregnancy test at the baseline visit, are pregnant or lactating, or are planning to become pregnant during the study period
- Have history of uterine, cervical or vaginal cancer during the past 3 years
- Clinically significant vaginitis at baseline visit
Key Trial Info
Start Date :
November 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02246270
Start Date
November 28 2017
End Date
December 1 2024
Last Update
December 13 2023
Active Locations (1)
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1
University of Oklahoma-Tulsa OB/GYN Dept and OU-Physicians
Tulsa, Oklahoma, United States, 74135